Stockholm, 2014-02-12 08:30 CET (GLOBE NEWSWIRE) -- The first part of the study, the dose-escalation part (with PledOx ® 2 and 10 ?mol/kg) in order to determine tolerability and the correct dose level, has been completed.
The conclusion from the first part of the study is that the patients have tolerated both doses of PledOx well.
The raw data from the dose-escalation part have now been compiled in a preliminary analysis. One can observe that, unlike during normal FOLFOX treatment of colorectal cancer, no moderate or serious neuropathies (grade 2 or higher) were observed despite up to 8 cycles of FOLFOX. This was seen for both doses of PledOx. The expected outcome without PledOx-treatment is that approximately 30% of the patients will develop neuropathies of grade 2 or worse after 8 cycles.
“What impresses most on the oncologists that we have talked to was the fact that PledOx seems to reduce the risk of chemotherapy induced sensory nerve disorders known as neuropathies. The reason for this being that chemotherapy induced neuropathy is a major clinical problem and the main reason for discontinuing oxaliplatin-based chemotherapy" says CEO Jacques Näsström.
In addition, it seems that the low dose in particular appears to have the potential to reduce serious (grade 3) white blood-related side effects such as decrease in neutrophils. Neutrophils are an essential type of white blood cells in defending the body against bacterial infections.
According to these data, the lower dose of PledOx will give the best effect. PledPharma has therefore applied to the regulatory authorities for reduction of the higher dose of 10?mol/kg to 5 ?mol/ kg. The reduction is primarily based on the apparent better effect on white blood cell-related side effects with the lower dose of PledOx.
So far the new dose is approved in Sweden and in the U.S.
This change in dose also means that the full number (i.e. 42) randomized patients must be included in order to be able to statistically evaluate the new dose, which will result in an expansion of the study and an extension of the trial period.
Patients treated with the new dose will, however, replace the majority of patients that should have be treated with the higher dose of 10 ?mol/kg since the dose change occurs early on in the study.
The current estimate is that all patients should be included in the study before the end of 2014 and that overall (top-line) data should be available towards the end of the first quarter of 2015.
Currently, all six patients in the dose escalation part have completed their treatment. Furthermore, all patients being treated with FOLFOX in combination with bevacizumab have started their treatment and DSMB has now given its initial approval to continue the treatment with bevacizumab in combination with FOLFOX. In addition, three patients are included in the second part of the study (the randomized part) and at the high end of 20 centers are actively recruiting patients to the study and these centers have identified an additional handful of candidates to include in the study.
About PledOx ® PledOx (calmangafodipir) is a compound that among other properties prevents severe side-effects of chemotherapy in cancer treatment. PledOx has been shown to protect against "oxidative stress" - a condition in which the cell's most important protection is not sufficient against the levels of reactive oxygen/nitrogen species generated as a result of the chemotherapy treatment. By mimicking the enzyme manganese superoxide dismutase (MnSOD), PledOx boosts the cells endogenous protection and thereby prevents side-effects that otherwise would arise as a result of the "oxidative stress".
About colorectal cancer
Colorectal cancer is the third most common cancer related cause of death in the western world. Annually 450,000 people become ill in colorectal cancer on the seven largest markets in the western world. First line treatment in colorectal cancer is a combination treatment called FOLFOX (FOLinate, 5-FluoroUracil (5-FU), and OXaliplatin). FOLFOX gives rise to a better outcome than previous treatments, but severe side-effects constitute a significant problem. The side-effects result in that the planned chemotherapy dose cannot be administered. Less than half of the patients do not receive the prescribed dose. Consequently, there is a huge medical need to reduce the side-effects of FOLFOX.
For further information please contact:
Jacques Näsström, CEO
+46 737 13 09 79
jacques.nasstrom@pledpharma.se
About PledPharma
PledPharma is a Swedish pharmaceutical company that develops new therapies for prevention of life threatening diseases related to oxidative stress. The initial objective is to develop a drug, PledOx ® , that reduces the serious side effects associated with chemotherapy. The current market for supportive cancer care is some USD 10 billion. PledPharma also evaluates an existing medicines possibility to reduce the damage that occurs on the heart muscle when a patient suffers from myocardial infarction. In addition to these projects, the company is also evaluating opportunities of using the technology platform in other medical areas where there is a significant unmet medical need in other diseases. PledPharma has the potential to offer patients valuable and unique treatments for serious life-threatening diseases where there is an opportunity for "breakthrough therapy" designation. It also means that the company has the potential to offer shareholders a good return on their investment. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik Penser Bankaktiebolag is the Certified Adviser. For further information, please visit www.pledpharma.se
